drugset / Trial / NCT01723059
Standard Triple Therapy vs Sequential Therapy in Treatment of H Pylori Infection
Unknown
184 enrolled
Dallas VA Medical Center
Otsuka Pharmaceutical Development & Commercialization, Inc. · collab
RandomizedSingle-groupOpen-labelTreatment
Summary
Traditionally, H pylori infection has been treated with conventional triple therapy. This includes amoxicillin, clarithromycin and a proton pump inhibitor all given daily for 10-14 days. In Europe, the guidelines now advocate treatment of H pylori with sequential therapy which is 5 days of amoxicillin therapy with proton pump inhibitor followed by 5 days of clarithromycin, metronidazole, and proton pump inhibitor with better response rates. We hypothesize that H. pylori resistance pattern and treatment response rates observed in Europe will not be predictive of resistance patterns and response rates in the United States.
Timeline
- Start
- 2012-02
- Primary completion
- 2013-01
- Completion
- 2013-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 1000 mg | Oral |
| Subject | Clarithromycin | Small molecule | 500 mg | Oral |
| Comparator | Metronidazole | Small molecule | 500 mg | Oral |
| Subject | Omeprazole | Other / unclassified | 20 mg | Oral |